TENNacity Trial: A Pilot Test of Intersectional CBT Among Young Southern Black and Latino/x GBQ+ Men
25 août 2026 mis à jour par: Yale University
Southern TENNacity: An Open Pilot of LGBTQ-Affirmative CBT Adapted for Young Black and Latino/x Gay, Bisexual, and Queer Men in the US South
This open pilot involves testing the acceptability and feasibility of an intersectional, culturally responsive health intervention by piloting it among young Black and Latino/x gay, bisexual, and queer (GBQ+) men residing in Middle Tennessee.
Qualitative exit interviews will be conducted to provide information regarding intervention feasibility, acceptability, and refinement; changes in primary and secondary study outcomes will help assess efficacy potential.
Effective Skills to Empower Effective Men (ESTEEM), has been shown to decrease negative mental health symptomology and HIV risk behavior among a racially diverse sample of young GBQ+ men.
This study would inform the cultural adaptation of ESTEEM to fit the unique and intersectional experiences of Black and Latino/x GBQ+ men living in the South, and in particular within Middle TN.
The adaptation and group pilot stands to significantly improve stigma coping and the mental/sexual health of Black and Latino/x GBQ+ men in Middle TN-and in turn impact the HIV burden in the Southern US.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
These research activities seek to further the reach and cultural-appropriateness of a clinically effective evidence-based intervention (ESTEEM) by further adapting ESTEEM-conneCT (a group-based treatment designed for gay and bisexual men of color in Fair Haven, CT) for young Black and Latino/x GBM residing in Middle Tennessee.
The intervention study will take place in Nashville, TN with a partnership between the Nashville CARES and the Yale School of Public Health (YSPH).
This pilot will guide further refinement, identify facilitators and barriers to scaling up, and yield effect size estimates for powering future studies.
Type d'étude
Interventionnel
Inscription (Réel)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Tennessee
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Nashville, Tennessee, États-Unis, 37201
- Nashville CARES Community Clinic
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- identify as male
- anticipate 6-months of residential stability in Nashville (or surrounding service area)
- identify as gay, bisexual, or report past-12-month sex with a man
- identify as Black and/or Latino
- speak fluent English
- provide consent
Exclusion Criteria:
- exhibit symptoms of psychosis, mania, or gross cognitive impairment (assessed by a clinician during pre-assessment)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Adapted ESTEEM intervention
Participants will receive the adapted ESTEEM intervention over 11 sessions
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culturally-responsive behavioral health intervention
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Center for Epidemiological Studies-Depression Scale (CES-D) score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
The CES-D is a 20-item measure that assesses frequency of past-week depression symptoms (e.g., "I was bothered by things that usually don't bother me") on a 4-point scale from 0 (rarely or none of the time [less than 1 day]) to 3 (most or all of the time [5-7 days]).
The item scores are summed, with higher scores indicating greater risk for clinical depression.
Total score range 0-80.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Overall Depression Severity and Impairment Scale (ODSIS) score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
ODSIS is a 5-item self-report scale that asks participants to rate the severity and impairment associated with past-week symptoms of depression (e.g., "In the past week, when you have felt depressed, how intense or severe was your depression?") from 0 (little or none: Depression was absent or barely noticeable.) to 4 (extreme: Depression was overwhelming.).
The item scores are summed, with higher scores indicating greater severity and impairment.
Total score range 0-20.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Overall Anxiety Severity and Impairment Scale (OASIS) score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
OASIS is a 5-item self-report scale that asks participants to rate the severity and impairment associated with past-week anxiety symptoms (e.g., "In the past week, when you have felt anxious, how intense or severe was your anxiety?") from 0 (little or none: Anxiety was absent or barely noticeable.) to 4 (extreme: Anxiety was overwhelming.
It was impossible to relax at all.
Physical symptoms were unbearable).
The item scores are summed, with higher scores indicating greater severity and impairment.
Total score range 0-20.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Brief Symptom Inventory (BSI) score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
The 18-item BSI provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely).
The item scores are summed with higher scores indicating greater severity and impairment.
Total score range 0-72.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Suicidal Ideation Attributes Scale (SIDAS) score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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SIDAS is a 5-item self-report scale that assesses past-month frequency and controllability of suicidal thoughts, how close one has come to making an attempt, and distress and impairment associated with thoughts of suicide (e.g., "In the past month, how often have you had thoughts about suicide?").
Responses range from 0 (never or not at all) to 10 (always or extremely).
The item scores are summed, with higher scores indicating greater severity of suicidal ideation.
Total score range 0-50.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Short Inventory of Problems - Alcohol and Drugs (SIP-AD) score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use?).
The item scores are summed, with higher scores indicating greater problems related to drugs and alcohol.
Total score range 0-15.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Mean Recent HIV-risk Acts
Délai: Baseline (0-30 days before the start of the trial) and post-intervention (three months after the trial)
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Mean Number of Recent HIV-risk Acts self reported using the timeline follow-back method
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Baseline (0-30 days before the start of the trial) and post-intervention (three months after the trial)
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Psychological Health Change
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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The number of the mental health variables that change in the expected direction.
The eight psychological health variables include: depressive symptoms; anxiety; social anxiety; suicidal ideation; psychological distress; substance use problems; rumination; and assertiveness.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Sexual Health Change
Délai: Baseline (0-30 days before the start of the trial) and post-intervention (three months after the trial)
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The number of sexual health variables that change in the expected direction.
The four sexual health variables include: Recent HIV transmission risk acts; condom use self-efficacy; sexual compulsivity; and recent PrEP use.
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Baseline (0-30 days before the start of the trial) and post-intervention (three months after the trial)
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Social Interaction Anxiety Scale score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
A 20-item self-report scale that assesses fear, distress, and anxiety a person feels during general social interactions.
Responses range from 0 (Not at all characteristic of me) to 4 (Extremely characteristic of me).
The item scores are summed, with higher scores indicating greater level of social anxiety.
Total score range 0-80.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean score Ruminative Responses Scale - Brooding Subscale
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
The Brooding Subscale is a 5-item measure that assesses maladaptive cognitive patterns when feeling down, sad, or depressed (e.g., "Think 'why do I always react this way?'") on a 4-point scale from 1 (Almost Never) to 4 (Almost Always).
The item scores are averaged, with higher scores indicating greater ruminative brooding.
Total score range 0-4.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Rathus Assertiveness Schedule score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
The Rathus Assertiveness Schedule is a 30-item measure that assesses assertiveness and passivity (e.g., "I often have a hard time saying 'No.'") on a 6-point scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me).
The item scores are summed, with positive scores indicating higher assertiveness and negative scores indicating lower assertiveness or passivity.
Total score range 90 to -90.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Alcohol Use Disorders Identification Test (AUDIT) score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
The AUDIT assesses past-3-month alcohol and related problems across 10 items (e.g., "How often did you have a drink containing alcohol?") with varying numeric response options (0-4).
The item scores are summed, with higher scores indicating greater alcohol-related risk.
Total score range 0-40.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Mean score Safer Sex Self-Efficacy Questionnaire
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Condom use self-efficacy will be measured by calculating mean scores on the Safer Sex Self-Efficacy Questionnaire.
The Safer Sex Self-Efficacy Questionnaire is a 13-item measure that assesses confidence in avoiding having anal sex without a condom in different situations (e.g., "When you are with someone who is really hot?") on a 5-point scale from 1 (Not at all confident) to 5 (Extremely confident).
The item scores are averaged, with higher scores indicating greater condom use self-efficacy.
Total score range 1-13.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Sexual Compulsivity Scale score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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The Sexual Compulsivity Scale is a 10-item measure that assesses difficulties regulating sexual desire (e.g., "I think about sex more than I would like to") on a 4-point scale from 1 (Not at all lke me) to 4 (Very much like m).
The item scores are summed, with higher scores indicating greater Sexual Compulsivity.
Total score range 10-40.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Percent participants with recent PrEP use
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
Recent PrEP use will be measured by calculating proportions of participants who reported any PrEP use over the past 3 months.
Three types of PrEP were described before participants were asked, "Which methods of PrEP (Pre-Exposure Prophylaxis) administration have you used to reduce the risk of getting HIV over the past 3 months?
Select all that apply."
Answer options included Daily PrEP (i.e., 4-7 days a week), On-demand PrEP (i.e., the "2-1-1" schedule), Injectable PrEP (i.e., every two months), and I have not taken PrEP in any form over the past three months.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Stigma Coping Strategies
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Number of protective strategies that increased and risk-enhancing strategies that decreased.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Stigma Coping- Adaptiveness Scale score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
Coping response will be scored on a 5-point adaptiveness scale (created for this study) ranging from 1 (Definitely adaptive [or almost certainly so]) to 5 (Definitely maladaptive [or almost certainly so]) with higher scores indicating worse coping.
Total score range 1-5.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Internalized Homophobia Scale score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
The Internalized Homophobia Scale is a 9-item measure that assesses internalized homophobia on a 4-point scale from 1 (Never) to 4 (Often).
The item scores are summed, with higher scores indicating greater internalized homophobia.
Total score range 9-36.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Gay-Related Rejection Sensitivity Scale score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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The Gay-Related Rejection Sensitivity Scale is a 14-item measure that the likelihood of expecting rejection by heterosexuals in more or less ambiguous situations with answers on a scale ranging from 1 to 6 with higher scores indicating greater rejection.
Total score range 1-6.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Mean Outness Inventory (OI) score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
The OI is an 11-item scale designed to assess the degree to which lesbian, gay, bisexual, and queer individuals are open about their sexual orientation.
Responses on OI items indicate the degree to which the respondent's sexual orientation is known by and openly discussed with various types of individuals on a 7-point scale from 1 (person definitely does NOT know about your sexual orientation status) to 7 (person definitely knows about your sexual orientation status, and it is OPENLY talked about); if the person of group is not relevant to them, participants select 0 (not applicable to your situation; there is no such person or group of people in your life).
The item scores are averaged, with higher scores indicating greater sexual orientation disclosure.
Total score range 0-4.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Mean Sexual Orientation Concealment Scale (SOCS) score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
This version of the Self-Concealment Scale is a 6-item measure that assesses sexual ), a brief self-report measure assessing effort to conceal one's sexual identity in one's current life (e.g., "In the last 2 weeks, I have altered my appearance, mannerisms, or activities in an attempt to 'pass' as straight.")
on a 5-point scale from 1 (Not at all) to 5 (All the time).
The item scores are averaged, with higher scores indicating greater concealment.
Total score range 1-5.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Internalized Racism score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
Internalized racism will be measured as mean of participant scores on a 5-item measure that assesses negative thoughts and beliefs about one's own racial minority status.
Participants were presented with a question regarding their racial/ethnic identity (e.g., "How do you feel today about being a person of your racial/ethnic background?"), which they answer by completing five semantic differential scales, each ranging from 1 (a negative characteristic) to 5 (a corresponding positive characteristic): uncomfortable to comfortable, dissatisfied to satisfied, ashamed to proud, strong to weak, and self-accepting to self-rejecting.
The item scores are summed, with higher scores indicating greater internalized racism.
Total score range 5-25.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Mean Racism-Related Vigilance scale score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
The scale is a 7-item measure includes four items that assess (a) racial/ethnic vigilance (e.g., "try to prepare for possible insults from other people before leaving home") on a 4-point scale from 0 (Rarely) to 3 (Almost every day), total score range 0-3.and
(b) race-related sleep disturbance over the past four weeks (e.g., waking very early with trouble getting back to sleep) on a 5-point scale from 1 (At least once a week) to 5 (Never), total score range 1-5.
The item scores are averaged, with higher scores indicating greater race-related vigilance.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Anticipatory Race-Related Stress Subscale of the Prolonged Activation and Anticipatory Race-Related Stress Scale score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
The Anticipatory Race-Related Stress Subscale is a 4-item measure that assesses race-related anticipatory stress on a 7-point scale from 1 (Not at all stressful) to 7 (Extremely Stressful).
The item scores are averaged, with higher scores indicating greater race-related anticipatory stress.
Total score range 1-7.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Heterosexism & Cissexism in Communities of Color Subscale of the LGBTQ+ PCMS-R score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
This is a 6-item subscale measure that assesses perceived heterosexism within one's racial/ethnic community on a 7-point scale from 0 (Not applicable) to 6 (Always).
Then, participants are presented with directions reading, "Imagining if you were to experience ongoing anti-LGBTQ stigma within your racial/ethnic community, such as:" and all six subscale items were presented.
They are then asked, "If you were to encounter situations like these..." before encountering three follow-up questions to assess distress (e.g., "to what extent would the situation stress or bother you?").
The initial subscale score is multiplied by the stress score to compute stress related to heterosexism in one's racial/ethnic community, with higher scores indicating greater intracommunity heterosexism.
Total score range 0-30.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Racism within LGBTQ+ Communities Subscale of the LGBTQ+ PCMS-R score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
This is a 6-item subscale measure that assesses perceived racism in the White LGBTQ+ community (e.g., "I have felt misunderstood by White LGBTQ+ people because I am a POC.") on a 5-point scale from 1 (To a little extent) to 5 (To a great extent).
Then, participants are presented with directions reading, "Imagining if you were to experience ongoing racism within the LGBTQ+ community, such as:" and all six subscale items were presented.
They are then asked, "If you were to encounter situations like these..." before encountering three follow-up questions to assess distress (e.g., "to what extent would the situation stress or bother you?").
The initial subscale score is multiplied by the stress score to compute stress related to heterosexism in one's racial/ethnic community, with higher scores indicating greater intracommunity heterosexism.
Total score range 0-30.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Conflicts in Allegiances Scale score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
The Conflicts in Allegiances Scale is a 6-item subscale measure that assesses conflicts between the racial/ethnic and sexual orientation identities they endorsed previously within the survey (e.g., "I separate my [insert sexual orientation] and [insert racial/ethnic group] identities.") on a 7-point scale from 1 (Disagree strongly) to 7 (Agree strongly).
The item scores are averaged, with higher scores indicating greater identity conflict.
Total score range 1-7.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Queer People of Color Identity Affirmation Scale score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
This is a 12-item measure that assesses identity affirmation among LGBTQ+ people of color on a 7-point scale from 1 (Very strongly disagree) to 7 (Very strongly agree).
The item scores are averaged, with higher scores indicating greater Southern LGBTQ-POC identity strength.
Total score range 1-7.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Queer and Trans Black, Indigenous, and People of Color (QT-BIPOC) Resilience Measure score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
|
This is a 20-item subscale measure that assesses the ways oppression has shaped their individuals and community QT-BIPOC resilience on a 7-point scale from 1 (Strongly Disagree) to 7 (Strongly Agree).
The item scores are averaged, with higher scores indicating greater intersectional stigma resilience.
Total score range 1-7.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Stigma-Related Stress Change
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Number of the mental health variables that change in the expected direction out of the 13 psychological health variables.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)
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Perseverative Cognition Subscale Subscale of the Prolonged Activation and Anticipatory Race-Related Stress Scale score
Délai: Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)]
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The Perseverative Cognition Subscale Subscale is a 5-item measure that assesses race-related rumination on a 7-point scale from 1 (Not at all stressful) to 7 (Extremely stressful).
The item scores are averaged, with higher scores indicating greater race-related anticipatory stress.
Total score range 1-7.
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Baseline (0-14 days before the start of the trial) and post-intervention (three months after the trial)]
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Skyler Jackson, PhD, Yale School of Public Health
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
16 avril 2025
Achèvement primaire (Réel)
19 novembre 2025
Achèvement de l'étude (Réel)
19 novembre 2025
Dates d'inscription aux études
Première soumission
25 août 2026
Première soumission répondant aux critères de contrôle qualité
25 août 2026
Première publication (Réel)
28 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2000034419
- 1K01MH122316-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified qualitative and quantitative IPD will be preserved and shared with qualified researchers upon request.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .